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02/07/08 - USPTO Class 600 |  13 views | #20080033322 | Prev - Next | About this Page  600 rss/xml feed  monitor keywords

Systems and methods for measuring cervical dilation

USPTO Application #: 20080033322
Title: Systems and methods for measuring cervical dilation
Abstract: Systems and methods for measuring cervical dilation are provided that include two biocompatible fasteners affixed to opposing cervical or vaginal walls, and a biocompatible string coupled to the fasteners, yet free to slide between the fasteners. The string has ends extending outside the vaginal opening of the patient, so that changes in cervical dilation can be measured by monitoring the relative movements of the string ends. The heads of the screws are preferably concave, with a loop attached thereon, so that the string can be coupled to the screws by running the string therethrough. Further, the tips of the screws are preferably blunt, to minimize loss of blood and the possible risk of HIV infections.
(end of abstract)
Agent: Luce, Forward, Hamilton & Scripps LLP - San Diego, CA, US
Inventors: Gerald Feuer, Gerald J. Sanders
USPTO Applicaton #: 20080033322 - Class: 600588 (USPTO)


The Patent Description & Claims data below is from USPTO Patent Application 20080033322.
Brief Patent Description - Full Patent Description - Patent Application Claims  monitor keywords

FIELD OF THE INVENTION

[0001]The present invention relates to the measurement of cervical dilation during childbirth. More particularly, the present invention relates to systems and methods for measuring cervical dilation that include affixing biocompatible screws to opposing cervical walls, slidably connecting a biocompatible string to the screws, and measuring the retraction of the string as the cervix dilates.

BACKGROUND OF THE INVENTION

[0002]Cervical dilation is a critical indicator of the effectiveness of uterine contractions and of the progress of labor during the childbirth process. By measuring cervical dilation, a clinician can not only monitor the advancement of the fetus, but can also determine the most appropriate time for a patient to begin pushing, or when to administer labor stimulants or anesthetic agents. The extent of cervical dilation is also an important indicator for diagnosing abnormal conditions such as cephalopelvic disproportion or dysfunctional labor, and to decide whether a cesarian section has become necessary.

[0003]Cervical dilation measurements are typically performed through digital (finger-based) examinations, during which a clinician inserts the first and second fingers of a gloved hand into the vaginal canal and spreads them into the cervix. Cervical dilation is then empirically measured through an assessment of the distance between the two fingers. Therefore, the quality of this empirical measurement system is heavily dependent on the experience of the clinician and is inherently prone to error.

[0004]Because the clinician's digital measurements are typically compared against reference labor curves (referred to as the "Friedman curves" gin the medical profession) that plot cervical dilation vs. time, a clinician's ability to determine whether a patient's labor is normal or dysfunctional, and to act accordingly in a timely fashion, is severely limited by the inherent unreliability of the data points used to build the patient's labor curves.

[0005]Despite the use of gloves, digital vaginal exams may also cause infections of the fetal membranes (chorioamnionitis), of the lining and muscle of the uterus (endomyometritis), or of the infant (neonatal sepsis). Infection risks increase dramatically after the fetal membranes have been ruptured, forcing the clinician to limit the number of vaginal exams after the rupturing of the membranes protecting the amniotic cavity.

[0006]Devices have been proposed in the prior art to measure cervical dilation. For example, U.S. Pat. No. 4,141,345 to Allen et al. discloses a device for measuring cervical dilation that is essentially a V-shaped caliper having ends attached to opposite cervical walls. While providing a more reliable measurement than digital examination, Allen's device creates a physical barrier to the passage of the fetus, and is not disposable, requiring repeated sterilizations.

[0007]U.S. Pat. No. 5,658,295 to Krementsov discloses a scissors-like device having tips in contact with the cervical walls at one end, and a measuring gauge at the other end. Krementsov's device also creates a physical barrier to the passage of the fetus and is not disposable, requiring repeated sterilizations.

[0008]U.S. Pat. No. 6,039,701 to Sliwa et al. discloses a support structure that detects changes in cervical diameter by detecting changes in the size of the support structure. In its different embodiments, Sliwa's invention involves devices that require a plurality of components, that still create physical barriers to the passage of the fetus, and that are also not disposable, requiring repeated sterilizations.

[0009]U.S. Pat. No. 6,966,881 to Ben-Cnaan et al. discloses a cervical dilation monitor that includes an expandable device having opposing members that grip the cervical walls. Ben-Cnaan's device still creates a physical barrier to the passage of the fetus and is not disposable.

[0010]Therefore, it would be desirable to provide systems and methods for measuring cervical dilation that generate reliable and continuous measurements of the spreading of the cervical walls.

[0011]It would also be desirable to provide systems and methods for measuring cervical dilation that do not interfere with the passage of the fetus during childbirth.

[0012]It would further be desirable to provide systems and methods for measuring cervical dilation that are inexpensive to manufacture and disposable after use.

SUMMARY OF THE INVENTION

[0013]In view of the foregoing, it is an object of the present invention to provide systems and methods for measuring cervical dilation that overcome the drawbacks of previously-known designs and that provide a simple yet reliable indications of labor progress.

[0014]It is another object of the present invention to provide systems and methods for measuring cervical dilation that enable a clinician to assess changes in the cervical opening on a continuous basis.

[0015]It is also an object of the present invention to provide systems and methods for measuring cervical dilation that create no obstacles to the passage of the fetus through the vaginal canal upon childbirth.

[0016]It is yet another object of the present invention to provide systems and methods for measuring cervical dilation that are fast and simple to implement by a clinician.

[0017]It is a further object of the present invention to provide systems and methods for measuring cervical dilation that are inexpensive to manufacture and that are disposable after use.

[0018]These and other objects of the present invention are accomplished by providing systems and methods for measuring cervical dilation that include two biocompatible fasteners affixed to opposing cervical or vaginal walls, and a biocompatible string that is connected to the fasteners, yet that remains free to slide. The string has ends disposed outside the vaginal opening of the patient, so that changes in cervical dilation can be measured by measuring length changes in that portion of the string that extends outside the vaginal opening.

[0019]In one embodiment, the fasteners are screws that have shafts less than 5 mm long, to prevent a complete perforation through the cervical wall and contact with the fetus, both while the screws are being attached and later during childbirth. The heads of the screws are preferably concave, with a loop attached thereon, so that the string can be connected to the screws by running the string through the loops. Additionally, the tips of the screws are blunted, to minimize the risk of loss of blood and the related risk of HIV infection.

[0020]The screws may be made of a bio-absorbable material, for example, a polyglactic material, so that the screws can be left in place after childbirth and be absorbed by the patient's body over time.

[0021]In other embodiments, relative movements of the string ends are measured with a measuring device, and bell shaped clips may be positioned between the screws and the cervical walls, retaining any blood lost during screw penetration and acting as tamponades against the screw wounds.

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